MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC INTRAOCULAR LENS

Model Number	VICMO 13.2
Medical Device Problem Code	Misfocusing (1401)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm vicmo13.2 implantable collamer lens of -14.50 diopter was implanted into the patient's left eye (os) on (b)(6) 2023.Refractive surprise was reported, lens remains implanted.In the reporters opinion the cause of the event is user error.The reporter states that the device did not fail to perform as intended.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
B5- the reporter indicated that a 13.2mm vicmo13.2 implantable collamer lens of -14.50 diopter was implanted into the patient's left eye (os) on (b)(6) 2023.Refractive surprise was reported, lens remains implanted.In the reporters opinion the cause of the event is user error.The reporter states that the device did not fail to perform as intended.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.Claim # (b)(4).
Additional Manufacturer Narrative
B5 - on (b)(6) 2024 the lens was exchanged with a different model but same size lens.This resolved the problem.The status of the eye is "excelent".Claim #(b)(4).
Additional Manufacturer Narrative
H3 - device evaluation: the lens was returned dry in a microcentrifuge vial.Visual inspection found no visible damage.Dimensional inspection found the lens to be within specification.Functional inspection found that the returned lens did not meet original values measured at the time of manufacturing.H6 - work order search: no additional similar complaint type events within associated lots were found.H6 - type of investigation 3331 - device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Claim #(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18062883
• Report Number: 2023826-2023-04964
• Device Sequence Number: 7465333
• Product Code: MTA
• UDI-Device Identifier: 00840311302505
• UDI-Public: 00840311302505
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: VICMO 13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: 12/11/2023; 04/24/2024; 06/26/2024
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 12/11/2023; 04/30/2024; 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female